Low-grade glioma - null regimens

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The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main low-grade glioma page for regimens that include active anticancer treatment.


Adjuvant therapy

Observation

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Shaw et al. 2012 (RTOG 9802) 1998-2002 Phase 3 (C) PCV Inferior OS1

1Reported efficacy is based on the 2016 update.

Preceding treatment

  • RT x 54 Gy

References

  1. RTOG 9802: Shaw EG, Wang M, Coons SW, Brachman DG, Buckner JC, Stelzer KJ, Barger GR, Brown PD, Gilbert MR, Mehta MP. Randomized trial of radiation therapy plus procarbazine, lomustine, and vincristine chemotherapy for supratentorial adult low-grade glioma: initial results of RTOG 9802. J Clin Oncol. 2012 Sep 1;30(25):3065-70. link to original article contains dosing details in manuscript link to PMC article PubMed NCT00003375
    1. Update: Buckner JC, Shaw EG, Pugh SL, Chakravarti A, Gilbert MR, Barger GR, Coons S, Ricci P, Bullard D, Brown PD, Stelzer K, Brachman D, Suh JH, Schultz CJ, Bahary JP, Fisher BJ, Kim H, Murtha AD, Bell EH, Won M, Mehta MP, Curran WJ Jr. Radiation plus procarbazine, CCNU, and vincristine in low-grade glioma. N Engl J Med. 2016 Apr 7;374(14):1344-55. link to original article link to PMC article PubMed

Residual or recurrent disease, first-line therapy

Placebo

Regimen

Study Dates of enrollment Evidence Comparator Comparative Efficacy
Mellinghoff et al. 2023 (INDIGO) 2020-01 to 2022-02 Phase 3 (C) Vorasidenib Inferior PFS

No active antineoplastic therapy.

Eligibility criteria

  • Grade 2 glioma with no previous treatment other than surgery

Biomarker eligibility criteria

  • IDH-mutant

References

  1. INDIGO: Mellinghoff IK, van den Bent MJ, Blumenthal DT, Touat M, Peters KB, Clarke J, Mendez J, Yust-Katz S, Welsh L, Mason WP, Ducray F, Umemura Y, Nabors B, Holdhoff M, Hottinger AF, Arakawa Y, Sepulveda JM, Wick W, Soffietti R, Perry JR, Giglio P, de la Fuente M, Maher EA, Schoenfeld S, Zhao D, Pandya SS, Steelman L, Hassan I, Wen PY, Cloughesy TF. Vorasidenib in IDH1- or IDH2-Mutant Low-Grade Glioma. N Engl J Med. 2023 Aug 17;389(7):589-601. Epub 2023 Jun 4. link to original article PubMed NCT04164901
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